EPA Proposes Two Test Methods and Guidance for Bacterial Biofilms (October 2016)

The Environmental Protection Agency (EPA) is proposing two test methods and guidance for use on biofilm bacteria Pseudomonas aeruginosa and Staphylococcus aureus to assess the effectiveness of antimicrobials. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA regulates pesticides by requiring companies who plan to manufacture or market pesticide products to apply for product registration and submit data that supports their product claims and safety. Because antimicrobials are intended to suppress, destroy or mitigate the presence of microorganisms, the registration requirements for these pesticides involve special tests to ensure public health protection.

According to EPA’s notice, bacterial biofilms are groups of microorganisms that produce a sticky substance, allowing them to cling to hard surfaces, including health-care appliances. The material protects the bacteria from external threats, such as dehydration and interferes with antimicrobial products such as disinfectants.

EPA is opening a public comment period to clarify standard operation procedures and to collect feedback for the regulatory guidance. The comment period will last until December 5, 2016.